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Trial record 13 of 176 for:    Recruiting, Not yet recruiting, Available Studies | Chest pain

Modified HEART as Rule Out for Suspected ACS

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ClinicalTrials.gov Identifier: NCT03619733
Recruitment Status : Recruiting
First Posted : August 8, 2018
Last Update Posted : August 8, 2018
Sponsor:
Collaborators:
Royal Liverpool University Hospital
University of Liverpool
Information provided by (Responsible Party):
Aleem Khand, Aintree University Hospitals NHS Foundation Trust

Brief Summary:

Validation of modified HEART score as a rule-out criterion for MACE at 6 weeks: a 2 centre prospective observational cohort with a direct comparison to TIMI, GRACE and high sensitive troponin T at limits of detection

Detailed description:

The HEART score, as defined previously by Backus et al1, is a risk score specifically developed for acute chest pain/ suspected acute coronary syndrome. The conventional scoring system for the troponin component of HEART is as follows: Troponin <99th percentile =0 (in the case of Hstn T [Roche} 14ng/l, 99th percentile up to X3 URL (99th percentile)= 1 (HSTN T =14-42ng/L, >x3 URN =2 (HSTN T >42ng/l).

We have previously defined that the optimal rule-out strategy for suspected acute coronary syndromes may well be a modified HEART score in a single centre study. This study is to prospectively validate the use of this score in a prospective unselected cohort of patients with possible acute coronary syndrome at 2 large secondary care centres


Condition or disease Intervention/treatment
Chest Pain Other: no intervention

  Show Detailed Description

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1100 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 123 Months
Official Title: Does Modified Heart Score Incorporating Undetectable and 99th Percentile High Sensitivity Troponin T Limits Improve Early, Safe Discharge for Suspected Acute Coronary Syndromes
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : September 1, 2018
Estimated Study Completion Date : December 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chest Pain


Intervention Details:
  • Other: no intervention
    this is an observational study. no intervention is planned


Primary Outcome Measures :
  1. incidence of Major adverse cardiac event for patients with HEART score<=3 [ Time Frame: 6 weeks ]
    adjudicated myocardial infarction, urgent or emergency coronary revascularisation, all-cause Death


Secondary Outcome Measures :
  1. incidence of acute myocardial infarction for patients with HEART <=3 [ Time Frame: 6 weeks ]
    adjudicated centrally by 2 physicans blinded to heart scores and to colleagues score



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
consecutive presentations to A&E at 2 major urban hospital swith chest pain that the clinicans feel warrants a biomarker check for myocyte necrosis (high sensitive troponin) and presentation ECG
Criteria

Inclusion Criteria:consecutive presentations to A&E at 2 major urban hospital swith chest pain that the clinicans feel warrants a biomarker check for myocyte necrosis (high sensitive troponin) and presentation ECG

-

Exclusion Criteria:

primary presentation not chest pain

clear noncardiac cause of chest pain such as trauma life expectancy <1 year due to noncardiac pathology


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03619733


Contacts
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Contact: aleem khand 00441516002720 akhand31@aol.com

Locations
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United Kingdom
University Hospital Aintree Recruiting
Liverpool, United Kingdom, L97AL
Contact: Mohammed Obeidat, MBBS MRCP         
Contact: Aleem Khand, MBChB MRCP       aleem.khand@aintree.nhs.uk   
Royal Liverpool university hospital Recruiting
Liverpool, United Kingdom
Contact: Khalid Albouaini         
Sponsors and Collaborators
Aintree University Hospitals NHS Foundation Trust
Royal Liverpool University Hospital
University of Liverpool

Additional Information:

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Responsible Party: Aleem Khand, cosultant interventional cardiologist, Aintree University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03619733     History of Changes
Other Study ID Numbers: AintreeNHS
First Posted: August 8, 2018    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Aleem Khand, Aintree University Hospitals NHS Foundation Trust:
HEART score, troponins
Additional relevant MeSH terms:
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Chest Pain
Pain
Neurologic Manifestations
Signs and Symptoms